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Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen Clinical research trials and Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen. Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen clinical trial. Participants oftentimes recieve the most expert healthcare available for their Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.

Home > "E" Clinical Trials Conditions > Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen

Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen



Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen

For Condition: stage 2 breast cancer,stage 3A breast cancer,stage 1 breast cancer
Status: Suspended
Sponsor(s): National Surgical Adjuvant Breast and Bowel Project (NSABP) , National Cancer Institute (NCI)
Synopsis: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.
Details: OBJECTIVES: - Determine whether exemestane following 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival, and time to treatment failure in postmenopausal women with resected stage I, II, or IIIA breast cancer. - Determine the effect of tamoxifen withdrawal on bone, in terms of height, fractures, total alkaline phosphatase, bone mineral density, and biochemical markers in these patients. - Determine the effect of exemestane on bone after tamoxifen withdrawal in these patients. - Evaluate the quality of life of a subset of these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral exemestane daily for 2 years. - Arm II: Patients receive an oral placebo daily for 2 years. Quality of life is assessed at baseline and then every 6 months for 2 years. Patients are followed every 6 months for 3 years and then annually thereafter. PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed invasive adenocarcinoma of the breast at time of original diagnosis - Tumor confined to the breast and ipsilateral axilla on clinical exam (T1-3, N0-1, M0) (stage I-IIIA) - No ipsilateral lymph nodes clinically fixed to one another or to other structures (N2 disease) at time of original diagnosis - Prior surgical resection, including 1 of the following: - Total mastectomy and axillary dissection (modified radical mastectomy) OR - Lumpectomy and axillary dissection followed by breast radiotherapy - Prior sentinel node biopsy allowed under 1 of the following conditions: - Sentinel node biopsy must have been performed with a complete axillary dissection if the patient is not registered on NSABP B-32 - If registered on NSABP B-32 and the patient has a pathologically positive sentinel node or a sentinel node that is not identified by blue dye or radioactive tracer, a complete axillary dissection must have been done - Previously resected margins must be clear of invasive tumor and ductal carcinoma in situ - Currently disease free - Previously treated with tamoxifen for 57-66 months - Completed tamoxifen within the past 180 days - No bilateral malignancy or mass in the opposite breast suspicious for malignancy unless biopsy proven negative - No local, regional, or distant recurrence of disease or second primary breast malignancy (including contralateral breast cancer) - No advanced disease at time of original diagnosis (e.g., ulceration, erythema, infiltration of the skin or underlying chest wall [complete fixation], peau d'orange, or skin edema of any magnitude) - Tethering or dimpling of the skin or nipple inversion allowed - Current skeletal pain allowed if a bone scan and/or radiologic exam is negative for metastatic disease - Postmenopausal - Prior bilateral oophorectomy OR - Absence of spontaneous menstrual cycle for more than 1 year - FSH within the postmenopausal range if under 55 and had a prior hysterectomy without a bilateral oophorectomy - Hormone receptor status: - Primary tumor estrogen receptor (ER) positive AND/OR - Progesterone receptor positive - Borderline ER positive tumors allowed if previously treated with tamoxifen PATIENT CHARACTERISTICS: Age: - Post menopausal Sex: - Female Menopausal status: - See Disease Characteristics Performance status: - Not specified Life expectancy: - At least 10 years Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin normal Hepatic: - Bilirubin less than 2 times upper limit of normal (ULN) - SGOT or SGPT no greater than 2.5 times ULN - Alkaline phosphatase less than 2 times ULN - No systemic hepatic disease that would preclude study Renal: - Creatinine no greater than 1.5 times ULN - No systemic renal disease that would preclude study Cardiovascular: - No systemic cardiovascular disease that would preclude study Other: - No other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, surgically treated carcinoma in situ of the cervix, or surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast - No nonmalignant systemic disease that would preclude study - No psychiatric or addictive disorder that would preclude informed consent - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior adjuvant chemotherapy allowed if administered concurrently with or prior to tamoxifen Endocrine therapy: - See Disease Characteristics - No other concurrent systemic hormonal therapy (e.g., tamoxifen or raloxifene) - Estring or estrogen vaginal cream at 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week allowed - No concurrent estrogen, progesterone, clomiphene, testosterone, gonadotropin- releasing hormone, oral contraceptives, selective estrogen receptor modulators, or DHEA mustard Radiotherapy: - See Disease Characteristics - Prior post-mastectomy loco-regional radiotherapy or post-lumpectomy regional radiotherapy allowed Surgery: - See Disease Characteristics Other: - Prior participation in other adjuvant NSABP study allowed if study was reported in peer-review publication or tamoxifen was not a study drug - Concurrent bisphosphonates or calcitonin for prevention or treatment of osteoporosis allowed - Concurrent statins (simvastatin, pravastatin, fluvastatin, atorvastatin, lovastatin) or other drugs to control lipid levels allowed
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
TerryMamounas,  Study Chair,  Aultman Cancer Center

Huntsman Cancer Institute
Salt Lake City,  Utah,  84112
United States
 

Virginia Oncology Associates - Newport News
Newport News,  Virginia,  23606
United States
 

Cancer Center of Hawaii
Honolulu,  Hawaii,  96826
United States
 

Stanford University Medical Center
Stanford,  California,  94305-5408
United States
 

CCOP - Virginia Mason Research Center
Seattle,  Washington,  98101
United States
 

CCOP - Kansas City
Kansas City,  Missouri,  64131
United States
 

Thompson Cancer Survival Center
Knoxville,  Tennessee,  37916
United States
 

Joe Arrington Cancer Research and Treatment Center
Lubbock,  Texas,  79410-1894
United States
 

Baystate Medical Center
Springfield,  Massachusetts,  01199
United States
 

CCOP - Montana Cancer Consortium
Billings,  Montana,  59101
United States
 

Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke,  Virginia,  24014
United States
 

Norton Healthcare System
Louisville,  Kentucky,  40202-5070
United States
 

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia,  Pennsylvania,  19107-5541
United States
 

Clarian Health Partners Inc.
Indianapolis,  Indiana,  46206-1367
United States
 

Baptist Regional Cancer Institute - Jacksonville
Jacksonville,  Florida,  32207
United States
 

Hopital du Saint-Sacrement, Quebec
Quebec City,  Quebec,  G1S 4L8
Canada
 

CCOP - Dayton
Kettering,  Ohio,  45429
United States
 

University of Connecticut
Farmington,  Connecticut,  06032
United States
 

CCOP - Cancer Research for the Ozarks
Springfield,  Missouri,  65807
United States
 

Barrett Cancer Center
Cincinnati,  Ohio,  45267-0502
United States
 

CCOP - Carle Cancer Center
Urbana,  Illinois,  61801
United States
 

Lehigh Valley Hospital
Allentown,  Pennsylvania,  18103
United States
 

Morton Plant Hospital
Clearwater,  Florida,  33756
United States
 

CCOP - Scott and White Hospital
Temple,  Texas,  76508
United States
 

Montreal General Hospital
Montreal,  Quebec,  H3G 1A4
Canada
 

St. Mary's Hospital Center
Montreal,  Quebec,  H3T 1M5
Canada
 

CCOP - Oklahoma
Tulsa,  Oklahoma,  74136
United States
 

Franklin Square Hospital Center
Baltimore,  Maryland,  21237
United States
 

CCOP - Sioux Community Cancer Consortium
Sioux Falls,  South Dakota,  57104
United States
 

Lahey Clinic - Burlington
Burlington,  Massachusetts,  01805
United States
 

MBCCOP-Our Lady of Mercy Cancer Center
Bronx,  New York,  10466
United States
 

Methodist Hospital Cancer Center - Omaha
Omaha,  Nebraska,  68114
United States
 

Toronto Sunnybrook Regional Cancer Centre
Toronto,  Ontario, 
Canada
 

Alexian Brothers Medical Center
Elk Grove Village,  Illinois,  60007
United States
 

CCOP - Southeast Cancer Control Consortium
Winston Salem,  North Carolina,  27104-4241
United States
 

Cross Cancer Institute
Edmonton,  Alberta,  T6G 1Z2
Canada
 

Geisinger Medical Center
Danville,  Pennsylvania,  17822-2001
United States
 

Center for Oncology Research and Treatment, Medical City Hospital
Dallas,  Texas,  75230
United States
 

Allegheny General Hospital
Pittsburgh,  Pennsylvania,  15212-4772
United States
 

Jewish General Hospital - Montreal
Montreal,  Quebec,  H3T 1E2
Canada
 

Aultman Cancer Center
Canton,  Ohio,  44710
United States
 

Illinois Oncology, Ltd.
Belleville,  Illinois,  62221
United States
 

Kaiser Permanente Medical Center - Vallejo
Vallejo,  California,  94589
United States
 

Credit Valley Hospital
Mississauga,  Ontario,  L5M 2N1
Canada
 

Illinois Masonic Medical Center
Chicago,  Illinois,  60657
United States
 

Comprehensive Cancer Institute of Huntsville
Huntsville,  Alabama,  35801
United States
 

Comprehensive Cancer Center at Wake Forest University
Winston Salem,  North Carolina,  27157-1082
United States
 

Emory University School of Medicine
Atlanta,  Georgia,  30322
United States
 

CCOP - Kalamazoo
Kalamazoo,  Michigan,  49007-3731
United States
 

University of Arkansas for Medical Sciences
Little Rock,  Arkansas,  72205
United States
 

CCOP - Greenville
Greenville,  South Carolina,  29615
United States
 

CCOP - MainLine Health
Wynnewood,  Pennsylvania,  19096
United States
 

Providence Hospital - Southfield
Southfield,  Michigan,  48075-9975
United States
 

CCOP - Christiana Care Health Services
Newark,  Delaware,  19899
United States
 

CCOP - Ochsner
New Orleans,  Louisiana,  70121
United States
 

Rebecca and John Moores UCSD Cancer Center
La Jolla,  California,  92093-0658
United States
 

MBCCOP - San Juan
San Juan,  ,  00927-5800
Puerto Rico
 

CCOP - Illinois Oncology Research Association
Peoria,  Illinois,  61602
United States
 

Boston Medical Center
Boston,  Massachusetts,  02118
United States
 

Lucille Parker Markey Cancer Center, University of Kentucky
Lexington,  Kentucky,  43213
United States
 

Louisiana State University Medical Center - New Orleans
New Orleans,  Louisiana,  70112
United States
 

CCOP - Toledo Community Hospital
Toledo,  Ohio,  43623-3456
United States
 

CCOP - Greater Phoenix
Phoenix,  Arizona,  85006-2726
United States
 

Arthur G. James Cancer Hospital - Ohio State University
Columbus,  Ohio,  43210-1240
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

Camden-Clark Memorial Hospital
Parkersburg,  West Virginia,  26102
United States
 

Pacific Shores Medical Group
Long Beach,  California,  90813
United States
 

Cancer Research Network Inc.
Plantation,  Florida,  33324
United States
 

Royal Victoria Hospital - Montreal
Montreal,  Quebec,  H3A 1A1
Canada
 

Eastern Maine Medical Center
Bangor,  Maine,  04401
United States
 

Sylvester Cancer Center, University of Miami
Miami,  Florida,  33136
United States
 

CCOP - Grand Rapids
Grand Rapids,  Michigan,  49503
United States
 

Holden Comprehensive Cancer Center
Iowa City,  Iowa,  52242-1009
United States
 

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

Scripps Cancer Center
La Jolla,  California,  92037
United States
 

CCOP - Wichita
Wichita,  Kansas,  67214-3882
United States
 

CCOP - Marshfield Medical Research and Education Foundation
Marshfield,  Wisconsin,  54449
United States
 

Glens Falls Hospital
Glen Falls,  New York,  12801
United States
 

Comprehensive Cancer Centers of the Desert
Palm Springs,  California,  92262
United States
 

West Suburban Hospital Medical Center
Oak Park,  Illinois,  60302
United States
 

Sutter Cancer Center
Sacramento,  California,  95816
United States
 

CCOP - Northern Indiana CR Consortium
South Bend,  Indiana,  46601
United States
 

MD Anderson Cancer Center Orlando
Orlando,  Florida,  32806
United States
 

CCOP - Northwest
Tacoma,  Washington,  98405-0986
United States
 

CCOP - Santa Rosa Memorial Hospital
Santa Rosa,  California,  95403
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

CCOP - Colorado Cancer Research Program, Incorporated
Denver,  Colorado,  80224
United States
 

Cancer Institute of New Jersey
New Brunswick,  New Jersey,  08903
United States
 

California Cancer Center
Fresno,  California,  93720
United States
 

Akron City Hospital
Akron,  Ohio,  44309
United States
 

William Beaumont Hospital
Royal Oak,  Michigan,  48073
United States
 

Staten Island University Hospital
Staten Island,  New York,  10305
United States
 

New York Oncology Hematology, P.C.
Albany,  New York,  12208
United States
 

University of Texas Health Science Center at San Antonio
San Antonio,  Texas,  78284-7811
United States
 

Medical College of Wisconsin Cancer Center
Milwaukee,  Wisconsin,  53226
United States
 

Jewish Hospital of Cincinnati, Inc.
Cincinnati,  Ohio,  45236
United States
 

CCOP - Central Illinois
Decatur,  Illinois,  62526
United States
 

Utah Valley Regional Medical Center - Provo
Provo,  Utah,  84604
United States
 

British Columbia Cancer Agency
Vancouver,  British Columbia,  V5Z 4E6
Canada
 

CCOP - Northern New Jersey
Hackensack,  New Jersey,  07601
United States
 

Mercy Hospital Cancer Center - Scranton
Scranton,  Pennsylvania,  18501
United States
 

MBCCOP - University of New Mexico HSC
Albuquerque,  New Mexico,  87131
United States
 

CCOP - Metro-Minnesota
St. Louis Park,  Minnesota,  55416
United States
 

Green Mountain Oncology Group
Bennington,  Vermont,  05201
United States
 

Dwight David Eisenhower Army Medical Center
Fort Gordon,  Georgia,  30905-5650
United States
 

Newark Beth Israel Medical Center
Newark,  New Jersey,  07112
United States
 

Rush-Presbyterian-St. Luke's Medical Center
Chicago,  Illinois,  60612
United States
 

Michigan State University
East Lansing,  Michigan,  48824
United States
 

Chao Family Comprehensive Cancer Center
Orange,  California,  92868
United States
 

CCOP - Missouri Valley Cancer Consortium
Omaha,  Nebraska,  68106
United States
 

St. Louis University Health Sciences Center
St. Louis,  Missouri,  63110-0250
United States
 

CCOP - Evanston
Evanston,  Illinois,  60201
United States
 

Centre Hospitalier de l'Universite de Montreal
Montreal,  Quebec,  H2L-4M1
Canada
 

South Pointe Hospital - Cancer Care Center
Warrensville Heights,  Ohio,  44122
United States
 

CCOP - Merit Care Hospital
Fargo,  North Dakota,  58122
United States
 

City of Hope Comprehensive Cancer Center
Duarte,  California,  91010-3000
United States
 

Tulane University Medical Center
New Orleans,  Louisiana,  70112
United States
 

Abbott-Northwestern Hospital
Minneapolis,  Minnesota,  55415
United States
 

St. Luke's Medical Center
Milwaukee,  Wisconsin,  53215
United States
 

Halifax Medical Center
Daytona Beach,  Florida,  32114
United States
 

Loma Linda University Cancer Institute
Loma Linda,  California,  92354
United States
 

Eastern Virginia Medical School
Norfolk,  Virginia,  23507
United States
 

University of Colorado Cancer Center
Denver,  Colorado,  80010
United States
 

CCOP - St. Louis-Cape Girardeau
St. Louis,  Missouri,  63141
United States
 

CCOP - Iowa Oncology Research Association
Des Moines,  Iowa,  50309-1016
United States
 

Medical College of Georgia
Augusta,  Georgia,  30912
United States
 

CCOP - Duluth
Duluth,  Minnesota,  55805
United States
 

East Carolina University School of Medicine
Greenville,  North Carolina,  27858-4354
United States
 

CCOP - Mount Sinai Medical Center
Miami,  Florida,  33140
United States
 

Oncology Hematology Consultants
Sarasota,  Florida,  34239
United States
 

Puget Sound Oncology Consortium
Seattle,  Washington,  98109
United States
 

Vermont Cancer Center
Burlington,  Vermont,  05405-0075
United States
 

Sutter Health Western Division Cancer Research Group
Greenbrae,  California,  94904
United States
 

Reading Hospital and Medical Center
Reading,  Pennsylvania,  19612-6052
United States
 

CCOP - Columbia River Oncology Program
Portland,  Oregon,  97213
United States
 

CCOP - Columbus
Columbus,  Ohio,  43206
United States
 

CCOP - Michigan Cancer Research Consortium
Ann Arbor,  Michigan,  48106
United States
 

St. Vincent Hospital
Green Bay,  Wisconsin,  54307-3508
United States
 

Genesis Medical Center
Davenport,  Iowa,  52803
United States
 

CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse,  New York,  13217
United States
 

Albert Einstein Cancer Center
Philadelphia,  Pennsylvania,  19141
United States
 

Henry Ford Health System
Detroit,  Michigan,  48202
United States
 

CCOP - Southern Nevada Cancer Research Foundation
Las Vegas,  Nevada,  89106
United States
 

York Cancer Center
York,  Pennsylvania,  17315
United States
 

Tom Baker Cancer Center - Calgary
Calgary,  Alberta,  T2N 4N2
Canada
 

Camcare Health
Charleston,  West Virginia,  25304
United States
 

Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego,  California,  92120
United States
 

National Naval Medical Center
Bethesda,  Maryland,  20889-5000
United States
 

Massey Cancer Center
Richmond,  Virginia,  23298-0037
United States
 

Consultants in Blood Disorders and Cancer
Louisville,  Kentucky,  40207
United States
 

Lincoln Medical and Mental Health Center
Bronx,  New York,  10451
United States
 

Hartford Hospital
Hartford,  Connecticut,  06102-5037
United States
 

North Idaho Cancer Center
Coeur D Alene,  Idaho,  83814
United States
 

St. Vincent Hospital and Health Care Center
Indianapolis,  Indiana,  46260
United States
 

CCOP - Upstate Carolina
Spartanburg,  South Carolina,  29303
United States
 

George Washington University Medical Center
Washington D.C.,  District of Columbia,  20037
United States
 

University of Pittsburgh Cancer Institute
Pittsburgh,  Pennsylvania,  15213-3489
United States
 

Simmons Cancer Center - Dallas
Dallas,  Texas,  75235-9154
United States
 

Baylor College of Medicine
Houston,  Texas,  77030
United States
 

Ellis Fischel Cancer Center - Columbia
Columbia,  Missouri,  65203
United States
 

Berkshire Medical Center
Pittsfield,  Massachusetts,  01201
United States
 

Alamance Cancer Center
Burlington,  North Carolina,  27216
United States
 


Additional Information:
Study ID Numbers:
  CDR0000068640;  NSABP-B-33,CTSU
Study Start Date: 
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016432

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3. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

4. Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

5. Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Primary Breast Cancer

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Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen

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